AN: 01155/2013
Revised: February 2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Hypermune Equine Plasma
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative CompositionQuantitative Composition
Frozen Equine PlasmaEquine IgG ≥ 24g/l
Equine Total Protein ≥ 50g/l
Excipient:
Acid Citrate Dextrose-A to ensure citrate content 10 - 20mmols/l
For a full list of excipients, see section 6.1.
3.PHARMACEUTICAL FORM
Plasma for intravenous infusion, after thawing.
4.CLINICAL PARTICULARS
4.1Target species
Foals from 24 hours to six days of age.
4.2Indications for use, specifying the target species
For foals with Failure of Passive Transfer
To raise the level of circulating IgG in neonatal foals which have been shown to have low levels (less than 4g/l). The raised level has been demonstrated approximately 24 hours after administration but the duration of the effect is not known.
4.3Contraindications
None
4.4Special warnings
None
4.5Special precautions for use
i) Special precautions for use in animals
Do not administer more than 2 doses to an animal.
If a second dose is required do not administer this before 24 hours.
To reduce risk of adverse reactions:
Transfusion Reactions. Careful monitoring, especially at the start and throughout the transfusion is essential. Distinction must be made between reaction to restraint and catheterisation and signs attributable to transfusion reaction. If tachycardia, hyperventilating or trembling occurs, the transfusion should be slowed down or stopped altogether. If signs abate within five minutes, as they should, then the transfusion should be continued. If they recur again, the transfusion should be stopped entirely.
Anaphylaxis. Careful monitoring, especially at the start and throughout the transfusion, is essential. If tachycardia, hyperventilating or trembling occurs, the transfusion should be slowed down or stopped altogether. If signs abate within five minutes, as they should, then the transfusion should be continued. If they recur again, the transfusion should be stopped entirely. If severe, or other signs occur such as colic, pyrexia, cardiac arrhythmias, urticaria and collapse, the transfusion should be stopped and if necessary epinephrine (0.01mg/kg), corticosteroids and intravenous saline administered. These emergency drugs should always be on hand. Flunixin meglumine at 0.25mg/kg may be used prophylactically to reduce the incidence of side effects.
Volume Overload. Volume overload is a possible hazard of plasma transfusion especially if the administration is carried out in foals compromised in any way or too quickly. Every foal should be fully clinically examined prior to transfusion and in the case of compromised foals the transfusion should be maintained at a slow rate, 1 litre for a 50 kg foal or pro rata in 1 hour. Careful monitoring throughout the transfusion is essential. If hyperventilating, respiratory distress or trembling occurs, the transfusion should be slowed down or stopped altogether. Diuretics may be used in severe cases.
ii)Special precautions to be taken by the person administering the veterinary medicinal product to animals
Administer only using a blood giving set to minimise risk of self-injection. In case of accidental contact with skin, wash affected areas thoroughly with warm soapy water.
4.6Adverse reactions (frequency and seriousness)
It should be noted that ACD-A is an excipient and that excess citrate may cause a reaction in the recipient foal. This may be seen as muscle fasciculations, weakness and cardiac abnormalities.
Transfusion Reactions are very rare; signs include tachycardia, hyperventilating and trembling.
Anaphylaxis is very rare, but can occur with products of this nature. Signs include tachycardia, hyperventilating and trembling, or other signs such as colic, pyrexia, cardiac arrhythmias, urticaria and collapse.
Volume Overload is a rare hazard of plasma transfusion especially if the administration is carried out in foals compromised in any way or too quickly. Signs include respiratory distress, hyperventilation, staggering and collapse when in standing restraint. Additionally, if the foal is in lateral recumbency froth may be seen at the nostril.
Measures to avoid these adverse reactions are detailed in section 4.5
4.7Use during pregnancy, lactation or lay
Do not use in pregnant or lactating horses.
4.8Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that Hypermune can be administered on the same day but not mixed with tetanus antitoxin.
No information is available on the safety and efficacy of Hypermune when used with any other veterinary medicinal product except the product mentioned above. A decision to use this product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
As with colostrum derived passive immunity, the passive immunity transferred by Hypermune may interfere with response to vaccine. It is recommended that this is considered when starting a vaccine programme with due adherence to the vaccine manufacturer’s instructions.
4.9Amounts to be administered and administration route
For foals with Failure of Passive Transfer
Hypermune may be administered to foals from 24 hours to 6 days of age where it has been shown after testing that they have low levels of serum IgG (less than 4 g/l). The dose required is one litre for a 50 kg foal (and pro rata, i.e. 20 ml per kg).
A blood sample should be collected from the foal approximately 24 hours later and re-tested for the level of serum IgG. If this is still low, a further dose may be administered. This should be given within 24 – 48 hours of the first administration and be given in the same manner as the first (intravenously, via a blood giving set, over 15 - 20 minutes).
Method of administration
The required dose is administered via a catheter placed in the jugular vein using a blood giving set equipped with a mesh filter. The product should be administered slowly, particularly at the start, and administration should take 15 – 20 minutes. Throughout the administration, the foal should be monitored for signs of adverse reactions.
Thawing should not take place in a microwave oven. The litre bag of plasma should be immersed only in warm water at not more than 40ºC. A water bath such as a sink full of domestic warm water is ideal. As the plasma thaws and the water cools, more warm water may be added as required but hot water (not greater than hand hot) must be avoided as it will damage the proteins. The entire litre of plasma should be brought slowly to body temperature before use to ensure all the cryoprecipitate is dissolved. Under optimum conditions this whole process may take 2-2½ hours. Occasionally small amounts of fibrin may still be seen floating in the plasma. It is not significant but must be filtered out by the filter in the blood administration set.
Inspect for leakage and if apparent on thawing the entire contents must be discarded.
4.10Overdose (symptoms, emergency procedures, antidotes), if necessary
No information is available on the effects of administering an overdose
Volume overload in foals
Volume overload is a rare hazard of plasma transfusion especially if the administration is carried out in foals compromised in any way or too quickly.
4.11Withdrawal period
Zero days.
5.IMMUNOLOGICAL PROPERTIES
To modulate the immune system by providing equine immunoglobulins.
ATC vet code: QI05AM.
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Acid Citrate Dextrose-A
6.2Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life once thawed: 24 hours
6.4.Special precautions for storage
Store in a freezer (-30°C to -20°C)
HYPERMUNE should be handled carefully when being unpacked and stored in the freezer. The bubble-wrap should not be removed as it protects the brittle frozen plastic which is susceptible to damage from careless handling such as being dropped or knocked in the freezer. When thawed it should be stored in a refrigerator.
6.5Nature and composition of immediate packaging
The container is a PVC with DEHP one-litre human plasma sterile transfer bag with two protective sterile ports. The whole bag is over wrapped with protective bubble wrap for storage and transport.
6.6Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
Veterinary Immunogenics Ltd
Carleton Hill
Penrith
Cumbria
CA11 8TZ
8.MARKETING AUTHORISATION NUMBER
Vm: 18513/4000
9.DATE OF FIRST AUTHORISATION
Date: 06 January 2003
10DATE OF REVISION OF THE TEXT
Date: February 2014
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
06 February 2014
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